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  • Just Answers - Future Shock: Voice Recognition Identification Technology

    Backgrounder: Kay Hughes, flight attendant for today' s non-stop coast-to-coast flight is busy checking her catering order and prepping the cabin. Bob Harmon is the captain and Jeff Mortowski is his first officer. Both are situated in the cockpit going over the pre-flight checklist. The pax are from various companies in the New York area or individuals on personal business who have bought seats on his flight.

    <
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    b>The Story: Kay woke up with a start as the alarm on her clock radio blared. Reaching across her pillow, she noticed the time, 5:15, and hammered the snooze button in the hopes of grabbing another five minutes of sleep. Tired as she was, her mind began to race as she considered the day ahead. In less than four hours she would be enroute to L.A. with an aircraft full of passengers. Slowly the thought of additional
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    leep became less important as she considered all that she had to do before leaving Teterboro. Quietly she slipped on her robe and slippers, poured herself a cup of coffee, and slinked into the shower.

    As Kay walked across the tarmac, she saw the fuel truck pulling up to her aircraft and the caterer at the gate waiting for a security clearance. It was 6:48 and already she could feel the heat lifting off of the pavement
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    . Another scorcher she thought; at least L.A. will be cooler.

    Kay greeted Jeff who was busy overseeing the fuel delivery; she then climbed onboard the G-V and gave a similar greeting to Bob who was occupied with updating paperwork. Bob finished what he was doing and briefed Kay with the day's schedule. Minutes later Kay turned to assist the approaching caterer with the day's order. Within the hour, the first of the pa
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    sengers began to arrive. Each sat in the lobby of the FBO waiting to be boarded. At precisely 8:00 a.m., Kay left the aircraft and walked down the ramp to the FBO. She whispered to the waiting security agent who signaled to the FBO customer service representative to make the boarding announcement. "Ladies and Gentlemen, Jet Aviation Flight #001 departing TEB for LAX is now boarding. Please present your identification c
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    rd and boarding pass to the security agent. Once you are cleared, you will be boarded. Thank you for flying Jet Aviation and enjoy your flight."

    Kay turned and left the FBO and walked back to the aircraft. Both pilots were onboard completing their preflight preparations. Kay stood at the bottom of the steps leading up to the aircraft waiting for the security agent to bring the passengers to the plane. She knew that wi
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    th fourteen passengers the security clearance would take a bit longer than normal.

    Kay considered waiting inside the cabin to keep cool, but knew that it was important that she greet the passengers at the base of the steps in case one of them needed assistance climbing up." It must already be 85 degrees out here," she thought as she watched the heat vapors rise off the pavement.

    After what seemed like an inordinate d
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    lay — Kay's hair was slowly losing style in the heat — Bob poked his head out of the cockpit and said, "Sorry for the delay, but we caught another one." Startled, Kay stammered, "You mean one of the passengers failed security clearance?" Bob replied, "Not only that but he is on the FBI's wanted list of suspected terrorists. The remaining passengers checked out okay, but we'll be delayed until the agents finish intervie
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ing them to see if they knew the guy." Despite the heat, Kay shivered as she thought of the potential chain of events a terrorist onboard the aircraft might unleash.

    Her fears gradually subsided when Jeff reminded her that the VOICE RECOGNITION IDENTIFICATION TECHNOLOGY (VRIT) unit in the FBO was flawless in the nearly six months of use. Over that time, twenty-six people with a criminal element were pulled, most of wh
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    om had been charged previously with petty crimes [such as tax evasion] and were either on the run or would be in violation of their parole restrictions had they left the state. Today marked the first time that a suspected terrorist was caught and as the squad car sirens wailed, Kay knew that this day would be anything but normal.

    The above account is fiction, but it pre-supposes a couple of things that could oc
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ur in the intervening years that would bring about similar results, i.e., additional and more widespread terrorist attacks being a primary consideration. In addition, a change in the way we do business, i.e., selling seats to individuals instead of selling the entire flight to a company or an individual would have to occur — no longer would you have a lead passenger who could identify all of the other passengers. VRIT
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    s now within reach and will, more than likely, become the norm of the day. Essentially, it works this way: a person speaks into a device that immediately matches the voice pattern with one in the database. The database identifies the person and when a match is made, the person is cleared [unless the database turns up a warrant for their arrest].

    Naturally, in order to get onboard a flight we would require passengers t
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    o be part of that database. This could occur if VRIT becomes as mandatory as holding a social security number or a driver's license. Foreign nationals would have to be keyed into the same system to make it work, so the potential for a worldwide Orwellian-type system would be great.

    Recently, I had the opportunity to meet with Russ Cooper, a managing partner with COMPUTEK, a Wall Street company that has developed the l
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    test generation of VRIT. He shared with me that both the FBI and CIA use an older generation of VRIT and his company is marketing the current one. Their customer base potential is impressive: government agencies, security firms, airports, airliners, automobile manufacturers, you name it. Wherever a positive i.d. on a person is needed, their technology might be utilized.

    According to Russ, the technology is fail-safe.
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    hen I mentioned that a voice impersonator like a Richard Little type could sneak by, he claimed that VRIT would still know who he was even with the "Richard Nixon" voice. Apparently, voice patterns are distinguishable even when disguised.

    We did not discuss "price" as he was not marketing his product directly to me. I can only imagine that the costs involved would be significant, but then I began to think that they co
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    uld possibly be offset by lower insurance premiums if insurance companies see the benefit of “guaranteeing” passenger security.

    So what role could the flight attendant play in utilizing VRIT? Perhaps in lieu of a security agent [especially in out of the way places like Bozeman, Montana], a VRIT unit would be assigned to your aircraft — much like a cardiac defibrillator monitor — and you would greet each passenger as
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    hey boarded the aircraft. Before the aircraft could be cleared for takeoff, the passengers would speak into the handheld VRIT and be given a security clearance on the spot.

    Let's return to our story and amend it with the security check being placed directly in the flight attendant's hands:

    Kay walked down the G-V's steps carrying her mobile VRIT device and waited as the passengers exited the FBO and made their
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    way to the aircraft. She announced, "Welcome onboard Jet Aviation flight #001 bound for Los Angeles. Please speak your name into the VRIT unit. Once you have been cleared, you may proceed up the steps. The first officer will take your boarding pass and you may be seated. If you need additional assistance, the captain will be glad to help you."

    One by one the passengers filed by, stating their name and waiting for the
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    green clearance light to flash. As they spoke, a signal was transferred to an orbiting satellite and then beamed to VRIT headquarters in Washington, DC. As the last of the passengers approached, Kay continued to greet each one and wait for clearance. Finally, when all passengers were cleared, she climbed the steps and had both pilots speak into the VRIT unit. At last, Kay placed the unit in the First Officer’s hands in
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    order to have him run clearance on her. Kay cleared her throat, spoke her name, but after an extended pause, the VRIT beeped loudly and signaled red. The color in Kay's face drained away and she turned to flee. Within moments several arms reached forward to apprehend her as sirens wailed in the background.

    All she could think about was running away...

    Startled, Kay awoke from her dream as the snooze alarm blared away


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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